An interventional study of Conventional Labial Fixed Orthodontic Appliance and 3D-BOT Using E-WIRE Archwires in Mild-to-Moderate Mandibular Anterior Crowding, sponsored by University of Aleppo. Not yet recruiting at 1 site in Syria. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Aleppo · Not applicable, Interventional, and Treatment
This study will compare two fixed orthodontic treatments for mild-to-moderate crowding of the lower front teeth in adults. Participants will be randomly assigned to three-dimensional bracketless orthodontic treatment (3D-BOT), which uses wires bonded directly to the teeth, or conventional braces attached to the front surfaces of the teeth.
The main aim is to compare how tooth alignment changes during the first 24 weeks after appliance placement. Additional assessments will examine changes in tooth position and lower dental arch dimensions, oral and gum health, soft-tissue effects, quality of life and psychosocial well-being, patient experience and satisfaction, pain and painkiller use, appliance failures, time spent on clinical procedures and digital preparation, and changes in teeth and supporting bone. Data will be collected through clinical examinations, digital scans, questionnaires, home diaries and radiographic imaging.
Adult orthodontic treatment requires a balance between alignment effectiveness, appliance visibility, comfort, oral hygiene, and treatment burden. Conventional fixed appliances do not depend on daily wear of a removable appliance, whereas clear aligners require adherence to prescribed wear. Three-dimensional bracketless orthodontic treatment (3D-BOT) aims to combine digitally planned, fixed wire-based mechanics with less conspicuous appliance placement. Its proposed clinical and patient-related advantages require comparative evaluation.
Recruitment process: Participants will be recruited consecutively from adults aged 18-25 years seeking treatment for mandibular anterior crowding at the Department of Orthodontics, Faculty of Dentistry, University of Aleppo. Potentially eligible patients will receive a verbal explanation and a written information sheet covering the study, both interventions, risks, anticipated benefits, follow-up requirements and voluntary participation, with an opportunity to ask questions. Written informed consent will be obtained before study-specific baseline procedures, and declining participation will not affect routine care. Final eligibility will be confirmed using Little's Irregularity Index measured on the pretreatment digital model.
Both groups will be managed using common pretreatment planning principles and clinical limits. The digital target setup and interproximal reduction (IPR) plan will be finalized before allocation disclosure; appliance-specific wire-position planning for 3D-BOT will follow allocation. In the 3D-BOT group, planned anterior fixation sites will be transferred clinically using each clinical crown's lingual long axis and the digitally recorded vertical distance from the wire centre to the incisal edge or canine cusp tip, with a bracket-positioning gauge and marker. Posterior wire positioning will use the central occlusal fossae and grooves as reference landmarks. Planned and delivered IPR will be documented separately, and subsequent clinically justified plan revisions will be dated and retained alongside the original plan.
At scheduled visits, research records and questionnaires will be obtained before appliance adjustment, replacement, or repair, and oral health assessments will precede professional cleaning. Digital scans will follow a standardized acquisition sequence, recording both arches and the bite at baseline and the mandibular arch only at follow-up. Scan completeness will be verified before files are saved in STL format under coded names in a separate research folder for each participant. Standardized measurement procedures will be applied to coded digital models and lateral cephalograms. Intra-assessor reliability and measurement error will be assessed through repeated measurements on a randomly selected subset of records, without access to previous readings. Patient-reported assessments will follow standardized instructions and instrument-specific recall periods. Pain and analgesic diaries will be anchored to actual appliance placement or activation.
Treatment progression will be guided by clinical suitability. Actual treatment received will be recorded, together with the timing and reasons for delays, repairs, rescue interventions, and deviations from the planned sequence. Discontinuation or modification of the assigned appliance will be distinguished from withdrawal of consent for research follow-up. Participants who discontinue or change their appliance will be invited to continue scheduled assessments if they consent. The primary analysis will follow the intention-to-treat principle, retaining the original randomized allocation, with prespecified handling of missing data and sensitivity analyses addressing protocol adherence and missing-data assumptions.
88 studies on the registry are indexed under Crowding; 22 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 74 interventional studies indexed under Crowding.
Browse Crowding studies →University of Aleppo is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive conventional labial fixed orthodontic treatment using metal brackets and a planned archwire sequence to align the mandibular anterior teeth.
Device: Conventional Labial Fixed Orthodontic Appliance
Participants will receive bracketless fixed orthodontic treatment using coated E-WIRE archwires secured with composite along a digitally planned path to align the mandibular anterior teeth.
Device: 3D-BOT Using E-WIRE Archwires
Mini Master Series metal brackets (American Orthodontics), MBT prescription with 0.022-inch slots, will be bonded to teeth 45-35, with buccal tubes on 46 and 36. Nickel-titanium (NiTi) archwires will follow the planned sequence (inches): 0.012 at APP0; 0.014 after T1 (Week 4); 0.016 after T2 (Week 8); 0.016×0.022 after T3 (Week 12); 0.017×0.025 after T4 (Week 16); and 0.019×0.025 at Week 20. Progression requires clinically appropriate engagement without excessive force; otherwise, the current wire will be retained and reassessed. A 0.019×0.025-inch stainless steel wire will be placed after all T5 (Week 24) research assessments. IPR will follow the plan locked before randomization. No chains, springs or other auxiliaries directly affecting lower anterior alignment will be used during evaluation. Actual wire changes, delays, repairs and clinically necessary deviations will be documented.
At APP0, a round coated E-WIRE (E-Wireligner; nominal size 0.014 inch) will be secured with GC Ortho Connect Flow (GC Orthodontics) from teeth 46 to 36 along a digitally planned posterior occlusal/anterior lingual path. After light curing, the water-soluble coating will be removed with a 60-second water wash. After the T2 (Week 8) digital scan, the initial wire and its composite will be removed, and a coated Velodrome E-WIRE (E-Wireligner; nominal size 0.016 × 0.022 inch) will be bonded to the lingual surfaces of teeth 43-33 only, using the same bonding and coating-removal procedures. IPR will follow the plan locked before randomization. No auxiliaries directly affecting lower anterior alignment will be used. Clinically necessary delays, repairs and deviations will be documented.
Longitudinal change in mandibular anterior Little's Irregularity Index (LII)
LII is the sum of five horizontal displacements between corresponding anatomical contact points of adjacent mandibular anterior teeth (43-33), measured in millimeters on digital models. Decreases from baseline indicate improved alignment.
Time frame: Baseline (T0, before initial appliance placement) and Weeks 4, 8, 12, 16 and 24 after initial appliance placement (APP0).
Alignment Progression and Time to Documented Alignment
Mandibular anterior alignment is assessed on digital models using Little's Irregularity Index (LII). Measures include interval LII reduction (mm), improvement rate (mm per four weeks, using scheduled interval durations), cumulative percentage improvement from baseline, proportion achieving LII ≤1 mm, and time (days) from initial appliance placement to the first scan documenting LII ≤1 mm.
Time frame: Baseline and Weeks 4, 8, 12, 16 and 24 after initial appliance placement. Time to documented alignment: from initial placement up to Week 24.
Changes in mandibular arch dimensions
Digital-model changes from baseline (mm) in intercanine cusp-tip width, first-premolar Pont width, first-molar middle-buccal-cusp width and anterior arch depth. Pont points lie at the distal marginal ridge/distal buccal-cusp-slope junctions. Depth is the greatest perpendicular distance from either lower central incisor's most labial incisal-edge point to the first-premolar Pont line.
Time frame: Baseline and Weeks 4, 8, 12, 16 and 24 after initial placement.
Changes in lower incisor inclination and protrusion
Changes from baseline on lateral cephalograms in the angles between the lower incisor's long axis and the mandibular plane (Go-Me) and nasion-point B line (NB), measured in degrees, and the perpendicular distance from its most labial crown point to NB, measured in millimeters.
Time frame: Baseline and Week 24 after initial placement, before treatment procedures.
Mandibular anterior rotation correction
Crown-axis angular deviations of the six lower anterior teeth from the digital target setup approved before randomization, measured in the reference occlusal plane. The main indicator is mean absolute error (MAE; degrees); root mean square error (RMSE; degrees) and percentage reduction from baseline MAE are supportive indicators. Lower angular errors indicate closer agreement with the target.
Time frame: Baseline and Weeks 4, 8, 12, 16 and 24 after initial placement.
Mean Silness-Löe Plaque Index Score
Mean Plaque Index score (0-3) across up to 48 sites on mandibular teeth 46-36. The mean is calculated from the sites actually assessed, with the number of assessed sites recorded. Higher scores indicate greater plaque accumulation.
Time frame: Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures.
Mean Löe-Silness Gingival Index Score
Mean Gingival Index score (0-3) across up to 48 sites on mandibular teeth 46-36. The mean is calculated from the sites actually assessed, with the number of assessed sites recorded. Higher scores indicate greater gingival inflammation.
Time frame: Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures.
Mean Papillary Bleeding Index Score
Mean Mühlemann Papillary Bleeding Index score (0-4) across up to 22 buccal and lingual papillary sides in the mandibular region 46-36. The mean is calculated from the papillary sides actually assessed, with the number assessed recorded. Higher scores indicate greater papillary bleeding.
Time frame: Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures.
Number and Percentage of Calculus-Positive Surfaces (Calculus Surface Index)
Number and percentage of calculus-positive surfaces on the four mandibular incisors (42, 41, 31 and 32), assessed on four surfaces per tooth (labial, lingual, mesial and distal). The count ranges from 0 to 16 when all surfaces are assessed; the percentage uses the number of surfaces actually assessed as its denominator. Higher values indicate more calculus.
Time frame: Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures.
Oral health-related quality of life
Arabic-language Oral Health Impact Profile-14 (OHIP-14), with a total score of 0-56 and a preceding-month recall period; higher scores indicate worse impact. Four separate descriptive indicators-oral function, orofacial pain, orofacial appearance and psychosocial impact-each range from 0-8.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 after initial placement, before clinical procedures.
Psychosocial impact of dental aesthetics
Arabic Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ-Ar): 23 items, with six dental self-confidence items reverse-scored, yielding a total of 0-92. Higher scores indicate worse psychosocial impact. Assessments characterize changes during treatment, with the appliance present at the final assessment.
Time frame: Baseline, Day 7, and Weeks 4, 12 and 24 after initial appliance placement; clinic assessments before treatment procedures.
Patient Experience and Satisfaction Assessed by Visual Analogue Scales
Study-specific 0-100 mm visual analogue scales assess appliance-related symptoms and functional and social impacts over the preceding 24 hours. Appliance-related satisfaction and willingness to choose the same appliance again or recommend it are assessed at Week 24 based on the participant's experience to date. Each item is analyzed separately; no overall score is calculated. Higher symptom and impact scores indicate worse experience, whereas higher satisfaction and willingness scores indicate more favorable responses.
Time frame: Experience: Days 1/7 and Weeks 4/12/24 after initial placement; also 24 h/7 days after the first non-round wire (planned Week 8 for 3D-BOT; Week 12 for control; actual dates used). Satisfaction: Week 24. Clinic ratings precede procedures.
Pain Intensity, Burden and Interference
Pain intensity is assessed using a 0-10 Numerical Rating Scale (0=no pain; 10=worst imaginable pain). Initial-placement pain burden is the trapezoidal area under the scheduled pain scores from 4 to 168 hours (score × hours), excluding the pre-procedure reading. Separate 0-10 ratings assess pain interference with sleep, mood, work/study and social life over the preceding seven days. Higher scores indicate greater pain or interference.
Time frame: Before initial placement/actual activation and 4, 24, 48, 72, 96, 120, 144 and 168 hours later; interference at Day 7. Sessions occur through Week 24. Initial-placement pain burden: 4-168 hours.
Analgesic Use, Dose and Time to First Dose
Measures include any analgesic use, number of days of use, number of doses, cumulative dose (mg) for each drug, and time to the first dose after the procedure. Different drugs are recorded and summarized separately. Analgesic use during the preceding 24 hours is recorded separately.
Time frame: During the 24 hours before and seven days after initial appliance placement and each actual activation through Week 24.
Clinical procedure, digital preparation time and treatment burden
The main comparison is cumulative net clinical procedure time (minutes), including initial application, planned procedures and repairs/unplanned interventions, but excluding isolation, interproximal reduction and non-procedural pauses. Initial application, planned-procedure and repair times are also reported separately. Additional 3D-BOT digital setup and wire-planning time is described separately and added to clinical time for a supplementary total; control-group research-only setup is excluded. Cumulative clinical time, unplanned visits, repair counts and repair time are additionally summarized up to the first scan documenting Little's Irregularity Index ≤1 mm, excluding subsequent procedures at that visit. Non-achievement by Week 24 is recorded.
Time frame: Planning through completion of Week 24 procedures, including final wire placement. Alignment-target burden ends before treatment at the first qualifying scan documented by Week 24.
Clinical appliance failure and failure patterns
Clinically confirmed unplanned loss of appliance stability or mechanical integrity requiring intervention. Outcomes include the proportion with failure, event counts and days to first failure. Events are classified by type, site, suspected cause, wire stage and same-site recurrence. A fixation unit is a bonded bracket/tube in conventional treatment or a composite fixation point in 3D-BOT. Each failed unit and recurrence after repair counts separately. Unit-related failure rates are expressed as events per fixation-unit-week of exposure. Failure timing is classified relative to the most recent placement or rebonding of the affected unit: immediate (0-24 hours), early (\>24 hours to four weeks), or late (\>four weeks). Time to the participant's first failure is measured from initial appliance placement and does not reset after repair or wire replacement.
Time frame: Initial appliance placement through the Week 24 assessment, before treatment procedures.
Incidence and Severity of New Oral Mucosal Lesions
Proportion developing new lesions, new-lesion count, maximum clinically assessed severity on a study-specific 0-4 scale (0=no lesion; 4=severe/multiple ulceration, marked speech/chewing difficulty or medication requirement), maximum diameter (mm), speech/chewing effects, medication need and percentage of scheduled assessments with lesions. Pre-existing lesions are recorded separately; persistent lesions count once and recurrence after resolution counts as new.
Time frame: Baseline; Days 1 and 7; Weeks 4, 8, 12, 16, 20 and 24 after initial placement, plus interim monitoring. Follow-up ends before Week 24 treatment procedures.
External root resorption of mandibular anterior teeth
Root shortening of the six mandibular anterior teeth, calculated as baseline root length minus Week 24 root length (mm) on paired cone-beam computed tomography images. Results are summarized per tooth and as the participant-level mean across evaluable teeth; the number of teeth assessed is recorded.
Time frame: Baseline and Week 24 after initial appliance placement.
Changes in mandibular anterior alveolar bone
Changes from baseline in buccal, lingual and interradicular bone thickness and alveolar crest level (mm) around the six mandibular anterior teeth, assessed using cone-beam computed tomography, together with the number and proportion of assessable sites showing radiographic dehiscence or fenestration. Non-assessable sites are documented.
Time frame: Baseline and Week 24 after initial appliance placement.
Short-term oral health-related quality of life
Arabic five-item Oral Health Impact Profile (OHIP5-Ar), with seven-day recall and a total score of 0-20. Higher scores indicate worse oral health-related quality of life. Total scores and changes from baseline are assessed regardless of whether the preceding visit included activation.
Time frame: Baseline and seven days after initial appliance placement and the Week 4, 8, 12, 16, 20 and 24 visits.
Orthodontic treatment impact on daily life
Arabic Orthodontic Treatment Impact Questionnaire (OTIQ-Ar): 21 scored items, with two positively worded items reverse-scored, yielding a total of 0-42. Higher scores indicate greater impact. The global question is analyzed separately on a 0-2 scale. Recall starts at initial placement for the Week 4 assessment, the Week 8 visit for the Week 12 assessment, and the Week 20 visit for the Week 24 assessment.
Time frame: Weeks 4, 12 and 24 after initial appliance placement, before treatment procedures.
Correlations Between Alignment Improvement and Space-Provision Measures
Exploratory correlation coefficients describing associations between the baseline-to-Week-24 reduction in Little's Irregularity Index and actual interproximal enamel reduction, changes in mandibular arch widths and anterior arch depth, and changes in lower incisor inclination and protrusion. Correlations are calculated using participant-level data.
Time frame: Changes from baseline to Week 24 after initial appliance placement.
Three-dimensional mandibular anterior tooth movement
Changes from baseline in crown and root-apex positions (mm), mesiodistal angulation and buccolingual inclination (degrees), and buccal/lingual root-to-cortical distances (mm), measured on cone-beam computed tomography (CBCT) images after regional registration on stable mandibular body bone. Digital intraoral scans may additionally be fused with the corresponding CBCT data to refine crown surface representation. Components are reported separately; non-assessable measurements are documented.
Time frame: Baseline and Week 24 after initial appliance placement.
Appliance Acceptance Assessed by an Arabic Questionnaire Adapted From Yuan et al. (2024)
An adapted Arabic questionnaire assesses appliance acceptance using symptom and functional-impact severity ratings (1-5), nominal and duration categories, and comfort and aesthetics ratings (0-10). Higher severity scores indicate worse symptoms or impacts; higher comfort and aesthetics scores indicate more favorable responses. Items are analyzed separately; no overall score is calculated.
Time frame: Week 24 after initial appliance placement, before treatment procedures.
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University of Aleppo